Journal of Pharmaceutical Care

N/A

Background: Bone marrow suppression (BMS) is one of the main complications of chemotherapeutic agents. Given its anti-inflammatory, anti-oxidant, and anti-apoptotic properties, silymarin, a flavonoid derived from Silybum marianum, has been used against chemotherapy-induced BMS. The purpose of this research was to elucidate the advantages of oral nano-silymarin as a supplement to XELOX (oxaliplatin and capecitabine) or m-FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) regimen in relieving BMS in patients with metastatic colorectal cancer.

Methods: A clinical trial was conducted on 60 individuals through a randomized, triple-blinded, placebo-controlled design. The participants received 70 mg capsules with 15% silymarin nano micelles or placebo capsules, twice daily after meals for the duration of six courses of XELOX or m-FOLFOX6, starting from the first day of treatment.  The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5 was applied to evaluate the grade of BMS following the third and sixth chemotherapy cycles.

Results: The nano-silymarin group had significantly lower median CTCAE scores for both thrombocytopenia and neutropenia at the end of the third course (P<0.001). However, the difference remained significant only for neutropenia at the end of the sixth course (P<0.001). On the other hand, nano-silymarin did not have protective effects against anemia. Moreover, based on the frequency of CTCAE grading scores, the differences remained significant until the end of the study for thrombocytopenia and neutropenia, but just until the end of the third course for anemia.

Conclusion: Nano-silymarin may display preventive effects against chemotherapy-induced bone marrow suppression, particularly neutropenia and thrombocytopenia in patients with metastatic colorectal cancer. However, further studies with larger sample sizes are required.

Background: Antimicrobial resistance is a highly serious healthcare-related issue of this era. Considering the burden of the global crisis of antimicrobial resistance, various strategies have been adopted worldwide. The Kerala Antibiotic Resistance Strategic Action Plan (KARSAP) is an action plan adopted in Kerala. It is the first of its kind, initiated by a state in India to tackle this global issue. Our objective is to evaluate the impact of the implementation of KARSAP, focusing on pharmacists’ knowledge and awareness of antibiotics and antibiotic resistance.

Methods: A questionnaire-based study was conducted among community pharmacies in a locality in Kerala, with a sample size of 50. The questionnaire was distributed by visiting each pharmacy and also involved a personal interview with the drug dispensers. The questionnaire was validated prior to the study. The results were statistically analysed to reach a conclusion.

Results: We observed a 100% response rate in our study. The majority of the respondents were registered pharmacists, and 26% of unqualified persons were also involved. Despite the rising crisis of antimicrobial resistance, many respondents are still unaware of antimicrobial resistance, and only 60% are aware of it. Although over-the-counter sales of antibiotics have reduced, people still request them. As a measure to reduce the burden of this crisis, the government of Kerala has initiated a policy named KARSAP. However, 68% of our study population was unaware of the key policy itself.

Conclusion: While some pharmacists possess a solid understanding of antimicrobial resistance, the broader pharmacist community remains largely uninformed about this issue. The study also identifies the areas of improvement necessary to make KARSAP a complete success.

Background: Cytochrome P450 2C19 (CYP2C19) exhibits polymorphism, with about 21 known allelic variants. Notably, the ^*17 allele is associated with increased enzymatic activity, culminating in enhanced CYP2C19 activity and the ultra-rapid metabolizer (UM) phenotype. This genetic variation has a profound impact on an individual's response to a wide range of medications. The primary objective of this study was to ascertain the prevalence of the CYP2C19^*17 allele among Iranian patients who have received drug-eluting stents.

Methods: This study was conducted to examine the genetic polymorphism of the CYP2C19 enzyme in 100 patients with drug-eluting stents (DESs) at Imam Hossein Hospital, Tehran, Iran. All participants were selected based on pre-defined inclusion criteria. Blood samples were obtained for DNA extraction, and CYP2C19 genotypes were subsequently analyzed through polymerase chain reaction (PCR) and gel electrophoresis.

Results: The ^*17 polymorphism was detected in 11% of the cohort. Of this group, 11 individuals were heterozygous carriers of the CYP2C19^*17 allele, whereas the homozygous ^*17/^*17 genotype was not observed in any participant.

Conclusion: Our findings demonstrate a low prevalence of the CYP2C19^*17 allele and an absence of the homozygous ^*17/^*17 genotype in the Iranian population. Despite its lower prevalence compared to other populations, the clinical implications of this allele are still considered highly significant.

Background: Severe COVID-19 is often associated with systemic inflammation and coagulopathy, which may influence clinical outcomes. Identifying prognostic biomarkers at ICU admission can aid in risk stratification and management.

Methods: In this retrospective study, 363 ICU-admitted patients with severe COVID-19 were evaluated. The primary outcome was in-hospital mortality; secondary outcomes included associations between inflammatory/coagulation biomarkers and mortality, and comparison of derived ratios with their individual components.

Results: Mortality was 62.8%. Non-survivors had significantly higher D-dimer (p = 0.047), ferritin (p = 0.057), ESR (p = 0.018), and PCT (p = 0.049), with lower lymphocyte counts (p = 0.058) and vitamin D levels (p = 0.002). NLR was markedly elevated in non-survivors (p = 0.037) and showed the best predictive value (AUC = 0.66), outperforming neutrophil and lymphocyte counts individually. PLR provided limited discrimination. Diabetes and hypertension were also associated with increased mortality.

Conclusion: Inflammatory and coagulation markers—particularly NLR, D-dimer, ferritin, ESR, PCT, lymphocyte count, and vitamin D—are useful predictors of mortality in critically ill COVID-19. Early recognition of these parameters may aid triage and optimize ICU resource allocation.

Background: Ventilator-associated pneumonia (VAP) is a common and serious complication of mechanical ventilation in intensive care units (ICUs). The current study evaluates the effectiveness of enteral glutamine (GLN) supplementation in preventing VAP in ICU patients.

Methods: This controlled, randomized clinical trial was performed on mechanically ventilated ICU patients who had a Clinical Pulmonary Infection Score (CPIS) of ≤ 6 within 48 hours of starting ventilation. Patients in the intervention group received 40 g of GLN during the first 48 hours after intubation, and this was continued for seven days. Both the intervention and control groups received standard preventive care. Outcomes were evaluated by comparing the incidence of VAP, the number of pneumonia-free days, and the duration of ventilation and ICU length of stay in each group.

Results: We analyzed the medical records of 613 patients to identify those who met the eligibility criteria for our study, resulting in a final cohort of 35 participants (16 in the intervention group and 19 in the control group). The present clinical trial did not reach its target sample size of 23 patients per group, primarily because of participant attrition and loss to follow-up. Our findings revealed no significant differences in the incidence of early, late, or overall VAP between the two groups. However, the number of pneumonia-free days was significantly higher in the intervention group compared to the control group (log-rank test: P-value= 0.05). Other secondary outcomes, such as mortality rate, and the duration of ICU stay, hospital stay, and mechanical ventilation, also showed no significant differences between the two groups.

Conclusion: The administration of oral GLN supplements has been associated with an increase in the number of pneumonia-free days among ICU patients; however, this benefit does not appear to reduce the incidence of VAP. Further high-quality studies are warranted to validate these observations and to investigate the potential efficacy of GLN supplementation within specific patient cohorts.

Background: Phlebitis is a common complication of intravenous therapy, marked by inflammation of the vessel wall and surrounding tissues. Its incidence varies widely, from 6.2% to over 70%, and is influenced by multiple factors. This review aimed to identify factors contributing to phlebitis to improve prevention strategies and patient care in clinical settings.

Methods: We conducted an integrative review of relevant articles, including clinical studies, meta-analyses, and case reports published up to October 2024. A comprehensive search was performed across PubMed, Google Scholar, Embase, and Scopus. Twenty-one studies were selected for analysis and summary.

Results: Based on the reviewed studies, several factors influence phlebitis incidence: patient-related factors, including age (older adults over 40 are generally at increased risk), gender, with inconsistent impact, and comorbidities such as diabetes, hypertension, and obesity; medication-related factors (drug irritancy, pH, osmolality, and particulate matter); and procedure-related factors (catheter placement and clinical practices)

Conclusion: Phlebitis risk is shaped by patient-, product-, and process-related factors. Understanding how these elements interact is essential for effective prevention and management. Further research will help clinicians develop strategies to reduce complications and improve outcomes.

Background: Metformin is the initial pharmacological intervention for managing type 2 diabetes mellitus (T2DM). However, its effectiveness for achieving optimal glycemic control diminishes over time, requiring the addition of other oral antidiabetic drugs (OADs) to the treatment regimen. The widespread adoption of metformin-based fixed-dose combinations (FDCs) in India necessitates an investigation into their impact on affordability and access. This study, therefore, undertook a cost variation analysis of available dual FDCs containing 500 mg of metformin to illuminate these implications.

Methods: The cost data were sourced from retail websites. We analyzed cost variation by calculating the cost variation percentage (CV%) and the average cost of all FDCs. The relationship among cost variation, average cost, and the number of manufacturing companies was statistically assessed using Pearson's correlation in Microsoft Excel.

Results: Among the 15 FDCs analyzed, the metformin + dapagliflozin combination exhibited the most substantial cost variation, reaching 436.2%. Conversely, the metformin + saxagliptin combination recorded the highest average cost per tablet, at 45.16 rupees (equivalent to 0.52$). A statistically significant negative Pearson's correlation was observed between the average cost of drugs and the number of manufacturing companies across all FDCs (r = −0.595, p = 0.019*) and in the metformin + dipeptidyl peptidase-4 inhibitors (DPP4is) group (r = −0.900, p = 0.037*).

Conclusion: In our study, the co-administration of metformin with the newer therapeutic agents (dapagliflozin and saxagliptin) demonstrated the highest variability in pharmaceutical pricing. This finding underscores the necessity for regulatory intervention regarding the costs of these FDCs within the Indian market.

Background: Platelet-rich plasma (PRP) contains over 20 growth factors and protein molecules that play a role in cell proliferation, differentiation, and regeneration. This study was designed to evaluate the impact of intrauterine PRP injection on women who have experienced recurrent implantation failure (RIF).

Methods: The present clinical trial involved 94 patients with RIF who were scheduled for in vitro fertilization (IVF). For the intervention (PRP) group, PRP was injected into the uterus using an intrauterine insemination catheter 24 to 48 hours before embryo transfer. The study then assessed and compared pregnancy rates between the intervention and control groups.

Results: This study found no significant baseline differences between the two groups. Endometrial thickness (ET) was comparable, measuring 7.50 ± 0.41 mm in the PRP group and 7.53 ± 0.56 mm in the control group. The PRP group exhibited significantly higher rates of both biochemical and clinical pregnancy. Specifically, the biochemical pregnancy rate was 64.6% (n = 39) in the PRP group compared to 19.6% (n = 9) in the control group (p < 0.001). Similarly, the clinical pregnancy rate was significantly higher in the PRP group at 50% (n = 24) versus 17.4% (n = 8) in the control group (p = 0.001).

Conclusion: The findings of this study reveal that the intrauterine injection of PRP prior to embryo transfer is a safe and affordable intervention that improves the pregnancy rate, with no major adverse effects observed.

Background: Adherence to type 2 diabetes mellitus (T2DM) guidelines helps achieve glycemic control and minimize complications. This study evaluated the adherence to the Indian Council of Medical Research (ICMR) guidelines for the management of T2DM.

Methods: In this cross-sectional observational study, 250 prescriptions of T2DM were collected to assess their adherence to ICMR guidelines.

Results: The mean HbA1c of the patients was 8.39%. Ideal fasting plasma glucose, postprandial plasma glucose, HbA1c, and blood pressure levels were achieved in 23.2%, 16.4%, 17.2%, and 46.4% of the prescriptions, respectively. Foot care, lifestyle modification, tobacco cessation, and HbA1c advice within the last 6 months were present in 8, 164, 7, and 104 prescriptions, respectively. Eye examination was advised in 44% of the prescriptions. When indicated, initiation or intensification of anti-diabetic drugs, aspirin, and anti-hypertensive drugs was done in 86.8%, 37.4%, and 98% of the prescriptions, respectively.

Conclusion: Adherence was low for glycemic control, foot care advice, initiation of aspirin, and anti-diabetic drugs according to BMI. Guidelines were frequently adhered to for blood pressure control, advice for lifestyle modifications, initiation or intensification of anti-diabetic and anti-hypertensive drugs. The study inferred the need for better adherence to ICMR guidelines, which could be achieved by their periodic revision in light of new research evidence.

This case report highlights the adulteration of over-the-counter weight gain supplements with undeclared glyburide, culminating in a life-threatening episode of hypoglycemia in a healthy young adult. A previously healthy 23-year-old man was admitted to the emergency department on April 10, 2022, following a brief episode of unconsciousness. Upon arrival, his blood glucose was found to be 30 mg/dL. He reported having taken one herbal weight-gain tablet daily for the preceding three days. His blood glucose level quickly returned to normal after an intravenous dextrose infusion. Liquid chromatography-mass spectrometry (LC-MS) analysis of the tablets detected the presence of glyburide. The patient did not experience any further hypoglycemic episodes while being monitored and was discharged in stable condition after a four-day hospitalization. This case highlights the significant risk posed by undeclared sulfonylurea adulteration in unregulated herbal supplements, as well as the importance of implementing routine post-market quality control and toxicological screening to protect public health and prevent serious adverse events.